Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.

Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.

Samsung Bioepis has become the latest firm to move an ustekinumab biosimilar into Phase III trials, with the firm’s SB17 proposed Stelara rival kicking off a study in plaque psoriasis patients.

Biosimilar interchangeability is a hot topic in the US, with the first FDA decision on a formal interchangeability designation expected this month. But across the industry, views differ dramatically on the desirability and likely impact of this additional standard to biosimilarity.